Neocare Temperature Monitor
by Vickers America Medical Corp.
510(k) K810792
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK810792 | Date29 Apr 1981 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FMZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5400
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 28 Sep 2026
The Neocare Temperature Monitor is a Class 2 medical device with product code FMZ, designed for use in general hospital settings. It is a temperature monitoring device that provides accurate temperature readings for patient care.
The device is manufactured by Vickers America Medical Corp. and was cleared through the Traditional 510(k) pathway on April 29, 1981, after a 37-day FDA review. It is supplied as a single unit and is intended for hospital use. The device is not specified as MRI safe and no information regarding sterility or reusability is provided.
Other devices from Vickers America Medical Corp.
Questions
AI-generated answers, 28 Sep 2026
What is the Neocare Temperature Monitor used for?
The Neocare Temperature Monitor is used to provide accurate temperature readings for patient care in general hospital settings.
Is the Neocare Temperature Monitor supplied as a single unit or in multiple units?
The Neocare Temperature Monitor is supplied as a single unit.
Is the Neocare Temperature Monitor specified as MRI safe?
No, the Neocare Temperature Monitor is not specified as MRI safe.
What is the regulatory pathway for the Neocare Temperature Monitor?
The Neocare Temperature Monitor was cleared through the Traditional 510(k) pathway.